O-PEP
PARI O-PEP is a prescription respiratory therapy device that helps clear mucus and secretions from the airways. It is intended for adults and children aged five years or older in home,…
PARI O-PEP is a prescription respiratory therapy device that helps clear mucus and secretions from the airways. It is intended for adults and children aged five years or older in home, hospital and subacute care settings.
The patient repeatedly exhales into the device against a movable ball. This creates expiratory resistance and oscillations transmitted through the airways, helping mobilize secretions so they can move upward for clearance.
Listed Item
PARI O-PEP System
Reuse and Restrictions
The small, nonsterile device is reusable by one patient and can be cleaned with soap and water. It must not be used in patients with pneumothorax, right ventricular insufficiency, coughing up blood or tuberculosis.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Shenzhen Gwode Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 2 |
Record
| Listed by | Pari Respiratory Equipment, Inc., United States |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K150044 |
| Record published | 2017-06-30 |
| Record revised | 2021-06-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 018F65 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 42 |
| Hudson RCI | Teleflex Medical LLC | 26 |
| AirLife™ | Airlife, Inc. | 11 |
| AIM | Vitalograph Ireland Ltd. | 9 |
| AirLife | Carefusion | 8 |
| Prochamber Assembly | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Threshold | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Hudson RCI | Medline Industries, Inc. | 5 |
| VersaPAP™ Positive Airway Pressure Device | Trudell Medical International | 4 |
| Curaplex | TRI-Anim Health Services, Inc. | 4 |
| Halyard | Owens & Minor Distribution, Inc. | 4 |
Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150044 | 2016-05-27 |
| K090829 | 2009-07-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.